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A meeting of the Circulatory System Devices Panel was held on March 4 and 5, 2002. On March 4, the Panel discussed, made recommendations, and voted on supplement to a premarket approval application, P920014/S016, for the HeartMate Vented Electric Left Ventricular Assist System (VE LVAS) manufactured by Thoratec, Incorporation. The device was approved for use as a bridge to transplantation in September 1998.
The Panel heard a presentation by the sponsor on the results of the REMATCH clinical trial to support the use of the device as a permanent heart pump for destination therapy. REMATCH stands for Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. This study was a prospective, multi-center, randomized study in which 67 patients were implanted with the VE LVAS and 61 patients received maximal medication alone.
The primary endpoint was improvement in survival. Secondary endpoints were
improvement in several functional measures: quality of life as measured by 5
separate questionnaires, 6 minute hall walk, number of hospitalizations, New
York Heart Association Class and VO2 as measured by cardiopulmonary exercise
testing. Safety was measured by the rate of anticipated and unanticipated adverse
events.
Following the FDA presentation, and after questioning the sponsor, the Panel
considered several discussion questions related to the PMA supplement. In particular,
FDA asked the Panel to:
Following these deliberations, the Panel voted 8 to 2 that the application be found 'approvable with conditions', citing concerns over device safety, and reliability. The panel also was concerned about the number of adverse events and reoperations and how to adequately inform the patient of these risks. The conditions outlined by the Panel were:
On March 5, the Panel discussed, made recommendations, and voted on a premarket approval application, P010031, for the Medtronic Corporation InSync ICD, Model 7272. The device is an implanted cardioverter defibrillator with the additional capability of biventricular pacing used in the treatment of life-threatening ventricular dysrhythmias and congestive heart failure.
The Panel heard a presentation by Medtronic on the results of the primary clinical studies used to support the safety and effectiveness of the InSync ICD. The study was a prospective, multi-center, double-blinded randomized study. The data presented to the panel was on 133 patients with Class III/IV congestive heart failure who were implanted and received treatment with the device and 124 control patients with Class III/IV were implanted with the device and did not receive resynchronization therapy.
There were 3 co-primary effectiveness endpoints:
These co-primary endpoints were evaluated statistically based on an adjustment for multiplicity.
The safety objectives were:
There were many secondary objectives.
Following the FDA presentation, and after questioning the sponsor, the Panel considered several discussion questions related to the PMA. In particular, FDA asked the Panel to:
Following these deliberations, the Panel voted on a motion that the application be found 'not approvable', citing many deficiencies in the data provided in the panel pack supporting the sponsor's claim of effectiveness and safety. The Panel voted 5 to 5 on this motion, with the acting chairperson breaking the tie with a vote against the motion.
A second motion was made for "approvable with conditions". The Panel again voted 5 to 5 and the acting chairperson broke the tie with a vote for the motion.
The conditions recommended by the Panel were:
Contact: Lesley Ewing M.D., Executive Secretary,
(301) 443-8320 ext. 161, lle@cdrh.fda.gov
Transcripts may be purchased from: (written requests only)
Miller Reporting Company
735 8th Street, SE
Washington, DC 20003
(202) 546-6666 (voice)
(202) 546-1502 (fax)
Or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice), (301) 332-1726 (fax)
Under normal circumstances, panel summary minutes are available 60-90 days
post meeting. Summaries are also available on the CDRH web site:
http://www.fda.gov/cdrh/panelmtg.html
Back to CDRH Advisory Committee Database
Uploaded March 8, 2002
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